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ISRCTN
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ISRCTN43546373
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ClinicalTrials.gov identifier
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Public title
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Premedication for intubation in neonates: a randomised controlled trial
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Scientific title
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Acronym
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PIN
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Serial number at source
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N/A
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Study hypothesis
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Elective endotracheal intubations are still commonly performed without premedication in many institutions. The hypothesis tested in this study was that morphine given prior to elective intubations in neonates would decrease fluctuations in vital signs, shorten the duration of intubation and reduce the number of attempts.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Endotracheal intubation in neonates
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Participants - inclusion criteria
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Newborn infants of all gestations admitted to one Neonatal Intensive Care Unit.
Infants of all gestations, admitted to McMaster University Medical Center level III NICU and considered likely to need an elective oral or nasotracheal intubation during their hospital stay, were candidates for inclusion in this study. Families were approached for consent as soon as possible after birth when an elective intubation during their hospital stay seemed likely: if their infant(s) was less than 30 weeks gestation, already ventilated (as endotracheal tubes are frequently changed after 10 days if clinical deterioration from a respiratory standpoint), was on NCPAP for respiratory distress or was needing an elective surgery. Others were approached when an elective intubation was needed. At the time of this study, our unit was a 33-bed level 3 NICU, caring for both inborn and outborn patients, and the referral center for 25000 annual deliveries, with 900-1000 admissions per year.
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Participants - exclusion criteria
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1. Absence of an intravenous access
2. Upper airway anomaly potentially leading to a difficult intubation
3. Cyanotic heart disease
4. Upper gastrointestinal obstruction (which would require a rapid sequence intubation)
5. Concurrent opioid administration.
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Anticipated start date
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01/12/1999
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Anticipated end date
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30/09/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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34
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Interventions
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Morphine 0.2 mg/kg IV compared to placebo 5 minutes before an endotracheal intubation
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Primary outcome measure(s)
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The study aimed to test the hypothesis that morphine 0.2 mg/kg would decrease fluctuations in vital signs, shorten the duration of the procedure and reduce the number of attempts. The primary outcome was the duration of severe hypoxemia, defined as Sp02 < 85% with a HR< 90/min. This was felt to be the most undesirable side effect of endotracheal intubation as cerebral blood flow in neonates is highly dependent upon heart rate.
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Secondary outcome measure(s)
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1. Duration of the procedure
2. Duration of hypoxemia (Sp02 < 85%)
3. Number of attempts
4. Maximum change in blood pressure from baseline
5. Occurrence of bradycardia (HR<90/min).
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Sources of funding
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Not provided at time of registration
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Trial website
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Publications
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2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15461825
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Contact name
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Dr
Brigitte
Lemyre
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Address
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CHEO, Dept of Pediatrics
401, Smyth Road
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City/town
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Ottawa
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Zip/Postcode
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K1H 8L1
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Country
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Canada
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Tel
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+1 613 737 8561
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Fax
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+1 613 737 8889
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Email
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blemyre@ottawahospital.on.ca
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Sponsor
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McMaster University (Canada)
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Address
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Division of Newborn Medicine
1200 Main Street West
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City/town
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Hamilton, ON
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Zip/Postcode
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L8S 4J9
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Country
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Canada
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Date applied
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19/10/2004
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Last edited
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25/08/2009
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Date ISRCTN assigned
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19/10/2004
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